A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)

Официальное название

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer's Disease

Обзор

This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.

Вмешательства

• Препарат RO7812653
  Participants will receive RO7812653 as per the schedule in the protocol
• Препарат Placebo
  Participants will receive placebo as per the schedule in the protocol

Первичные конечные точки

• Percentage of Participants with Adverse Events [Срок оценки: Up to approximately 40 weeks]
• Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores [Срок оценки: Up to approximately 40 weeks]

Вторичные конечные точки (3)

• Plasma Concentration of RO7812653 [Срок оценки: Up to approximately 40 weeks]
• Cerebral Spinal Fluid (CSF) Concentration of RO7812653 [Срок оценки: Up to approximately 40 weeks]
• Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7812653 [Срок оценки: Up to approximately 40 weeks]

Критерии участия

Критерии включения

• Probable AD dementia (consistent with National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia) \[McKhann et al 2011\] or Mild Cognitive Impairment (MCI) due to AD (consistent with the NIA-AA core clinical criteria for mild cognitive impairment due to AD) \[Albert et al 2011\]).
• Willingness and ability to complete all aspects of the study. The participant should be capable of completing assessments either alone or with the help of the study partner.
• Fluency in the language of the tests used at the study site.
• Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted).
• If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 8 weeks prior to screening and until randomization is required.
• Agreement not to participate in other research studies for the duration of this study.

Критерии исключения

• Any medical history or evidence of a condition other than AD that may affect cognition.
• Presence of any significant cerebral abnormalities that would contraindicate lumbar puncture, as assessed on MRI
• Any other significant cerebral abnormalities that the Investigator considers clinically significant
• History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder.'
• Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological medical conditions which are not stable and adequately controlled or which in the opinion of the investigator could affect the subject's safety in the study or interfere with the study assessments

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 4 центра

• Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry — London
• Southampton General Hospital — Southampton
• Queen Elizabeth Hospital — Glasgow
• National Hospital For Neurology and Neurosurgery — London

Испания · 3 центра

• Hospital General de Catalunya — Sant Cugat del Vallès
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitario Reina Sofia — Córdoba

Канада · 2 центра

• Toronto Western Hospital — Toronto
• Montreal Neurological Institute Clinical Research Unit — Montreal

Швеция · 2 центра

• Sahlgrenska Universitetssjukhuset — Mlndal
• Karolinska Universitetssjukhuset — Solna

Нидерланды · 1 центр

• Brain Research Center Amsterdam — Amsterdam

Идентификаторы

NCT: NCT07234942 · BP45770 · 2025-522101-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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